Welcome to Lab Dish, a new First Opinion column on regenerative medicine from Paul Knoepfler.
With all the uncertainties surrounding the Food and Drug Administration under Trump 2.0, the recent agency workshop I attended remotely on cell therapies and tissue-based products was reassuring in its normalcy. Still, a few things surprised me and could have major implications for the field moving forward.
The FDA’s Center for Biologics Evaluation and Research (CBER) ran the meeting, which also had some encouraging presentations on early cell therapy trials. The workshop was held just days after key leadership departures including the retirement of longtime Deputy Director Celia Witten. I see Witten’s absence as a big challenge for CBER. On the other hand, it was a relief to see Peter Marks still there at the meeting as the CBER director. If CBER is going to function well over the coming four years, we need Marks as the leader.